We, and our collaborators, are seeing outcomes in the laboratory and in animals not seen before. Such as:
◦Slowly-proliferating cancer stem cells, totally unresponsive to any other drugs and radiation, dying within hours of being exposed to our compounds
◦Cancer cells from tumor types such as brain cancer and melanoma that show poor response to standard therapies, being readily killed by our compounds
◦Commonly used chemotherapies that have little or no effect on cancer cells, having their potency enhanced 20-fold by our compounds
◦Normal human brain stem cells responding to our compounds by proliferating and producing fully differentiated brain cells (neurons)
◦Stem cells from embryos with various genetic disorders such as muscular dystrophies responding to our compounds and behaving normally.

Children fighting a life-threatening form of cancer could be treated with a revolutionary anti-cancer therapy as early as next year, following the formation of a research alliance to fast-track development of a drug pioneered by UNSW researchers.

Neuroblastoma 1

An untreated neuroblastoma cell

Children fighting a life-threatening form of cancer could be treated with a revolutionary anti-cancer therapy as early as next year, following the formation of a research alliance to fast-track development of a medicine pioneered by Australian researchers.

The Children’s Oncology Drug Alliance (CODA) unites the research and resources of UNSW Australia and its commercialisation arm, NewSouth Innovations, childhood cancer research charity The Kids’ Cancer Project, ASX-listed Australian biotechnology-company Novogen, and Nationwide Children’s Hospital, Columbus, Ohio, to accelerate development of a treatment purpose-built for neuroblastoma – the most common form of cancer in infancy.

Currently there is no medicine approved to treat neuroblastoma, a cancer that affects up to 100 children in Australia and around 650 in the United States each year. Childhood cancers – which claim the lives of three Australian children every week – are currently treated with chemotherapies that have been developed for adults with little consideration to the special needs of children.

“For too long, childhood cancers have been neglected despite the progress made with treatments for adult cancers. The Alliance brings together the science, expertise and funding to accelerate the development of a medicine that has the potential to change the way we treat solid cancers in children,” said Professor Peter Gunning, Head of the Oncology Research Unit at UNSW Medicine.

The Alliance will progress clinical trials of a unique form of anti-cancer therapy originally developed by Professor Gunning’s UNSW research team and funded by The Kids’ Cancer Project. Now being taken forward commercially by Novogen, the drug class known as anti-tropomyosins has been specifically tailored to selectively target the structure of the cancer cell, causing it to collapse without adversely impacting healthy cells.

The Dean of UNSW Medicine Professor Peter Smith, who has worked as a childhood oncologist and is Chair of The Kids’ Cancer Project’s Research Advisory Committee said: “These drugs are very promising and long overdue. They have the potential to be the most significant development in the treatment of childhood cancer in more than 20 years”.

Novogen acquired the anti-tropomyosin technology in 2013 and has used its drug discovery expertise to produce molecules substantially more potent than those originally developed.

Novogen CEO, Dr Graham Kelly, said, “The Holy Grail of childhood cancer therapy is a medicine that is effective against a tumour such as neuroblastoma, but doesn’t leave the sort of damage that the child then has to deal with for the rest of their life”.

“We believe the anti-tropomyosins we have developed have the potency, selectivity and safety profile to meet the special needs of children,” he said.

Novogen is currently finalising pre-clinical research, with the goal of commencing clinical studies in Australia and the United States in 2015. The aim is that the childhood trials will be progressed in parallel with trials of anti-tropomyosins for a number of adult cancers.

Professor Timothy Cripe, Chief of Paediatric Haematology/Oncology/Blood and Marrow Transplantation at the Nationwide Children’s Hospital in Columbus, Ohio, affiliated with The Ohio State University, said, “Our research has shown anti-tropomyosins to be highly effective at killing neuroblastoma cells and slowing their growth in animal models”.

“The Nationwide Children’s Hospital is a major centre in the US for treating children with neuroblastoma. We are eager to test an idea that has been some years in the making,” he said.

NewSouth Innovations’ COO, Dr Jim Henderson said, “It’s important that the cutting-edge research at UNSW is made available in the community. We are enthusiastic that the Alliance will advance UNSW research into an exciting new treatment option for children with cancer”.

The Kids’ Cancer Project has supported the anti-tropomyosin research program since its beginnings in 1998, providing funding of $9 million to date. The charity also aims to raise a further $2.7 million to support clinical trials of the new medicine in children with neuroblastoma who have exhausted other treatment options.

Mr Col Reynolds OAM, Founder of The Kids’ Cancer Project, said: “Thanks to the generosity of our donors, we have been able to fund the initial research and proof-of-concept studies. The Alliance with Novogen and the other CODA partners now provides the means to progress to the clinical trial phase.”

Mr Reynolds said The Kids’ Cancer Project would continue to fundraise to ensure that the next phase of research into a treatment for neuroblastoma was not delayed. He highlighted that childhood cancers are second only to breast cancer in terms of the number of years of life lost to cancer in Australia.

“The Alliance would like to see other groups join the cause. We are keen to partner with anyone who can contribute to the development of improved treatment options for children with cancer.”

The clinical trials due to start next year are the first important step towards this treatment becoming available to patients on a general basis; the process of which is expected to take a number of years.

Jeff Lang - President and Chief Executive Officer
Thanks Ed. Although we are not satisfied with our operating margin in Q1, we do know that they are temporary and based on strategic decisions. We were pleased with the revenue and bookings in the quarter and we are optimistic that Q2 and the remainder of 2015 will be much better, given our record level of backlog.

Or

Brian Drab - William Blair
Okay. And then moving into second quarter in terms of gross margin, it sounded like we should be expecting gross margin to be under pressure through the second quarter, because your comment was that it should improve in the second half. Is it fair to conclude that we should model kind of flat gross margin from first quarter to second quarter?
Jeff Lang - President and Chief Executive Officer
Correct. You are absolutely correct. And then we are looking for some nice – some solid uplift in the second half of – second half of ‘15 and more so in ‘16.

Yahoo! Finance Worldwide

Quotes are real-time for NASDAQ, NYSE, and NYSEAmex when available. See also delay times for other exchanges. Quotes and other information supplied by independent providers identified on the Yahoo! Finance partner page. Quotes are updated automatically, but will be turned off after 25 minutes of inactivity. Quotes are delayed at least 15 minutes. All information provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Yahoo! nor any of independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. By accessing the Yahoo! site, you agree not to redistribute the information found therein.